Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.

Reporting Groups

Description

Ziprasidone

Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Placebo

Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Ziprasidone

Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Placebo

Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

Number of Subjects Per Response on the School Placement Questionnaire: School Attendance

Measure Description

School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.

Time Frame

Baseline, Week 2, Week 6, ET

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups

Description

Ziprasidone

Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Placebo

Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values

Ziprasidone

Placebo

Participants Analyzed [Units: Participants]

189

87

Number of Subjects Per Response on the School Placement Questionnaire: School Attendance [Units: Participants]

Baseline: No absences (n=88, 42)

20

7

Baseline: Only a few absences (n=88, 42)

16

15

Baseline: Frequent absences (n=88, 42)

13

2

Baseline: Did not attend (n=88, 42)

26

7

Baseline: Not applicable or vacation (n=88, 42)

13

11

Week 2: No absences (n=82, 36)

19

8

Week 2: Only a few absences (n=82, 36)

14

9

Week 2: Frequent absences (n=82, 36)

11

4

Week 2: Did not attend (n=82, 36)

25

8

Week 2: Not applicable or vacation (n=82, 36)

13

7

Week 6: No absences (n=67, 24)

16

8

Week 6: Only a few absences (n=67, 24)

22

12

Week 6: Frequent absences (n=67, 24)

5

0

Week 6: Did not attend (n=67, 24)

13

0

Week 6: Not applicable or vacation (n=67, 24)

11

4

ET: No absences (n=12, 12)

1

0

ET: Only a few absences (n=12, 12)

4

0

ET: Frequent absences (n=12, 12)

2

5

ET: Did not attend (n=12, 12)

4

4

ET: Not applicable or vacation (n=12, 12)

1

3

Week 6 [LOCF]: No absences (n=89, 37)

18

8

Week 6 [LOCF]: Only a few absences (n=89, 37)

26

13

Week 6 [LOCF]: Frequent absences (n=89, 37)

11

4

Week 6 [LOCF]: Did not attend (n=89, 37)

21

4

Week 6[LOCF]: Not applicable or vacation(n=89,37)

13

8

No statistical analysis provided for Number of Subjects Per Response on the School Placement Questionnaire: School Attendance

19. Secondary:

Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance [ Time Frame: Baseline, Week 2, Week 6, ET ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.